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Coronavirus: AstraZeneca asks U.S. FDA to authorize COVID-19 antibody treatment

LONDON —
AstraZeneca, the Anglo-Swedish drugmaker that developed one of many first COVID-19 vaccines, has requested the U.S. Meals and Drug Administration to authorize the emergency use of an antibody remedy to forestall the illness.

The corporate mentioned Tuesday that the remedy, often known as AZD7442, can be the primary long-acting antibody mixture to obtain an emergency use authorization for COVID-19 prevention.

The remedy might assist defend individuals whose immune techniques do not reply adequately to vaccination, AstraZeneca mentioned.

Late-stage human trials confirmed that AZD7442 diminished the danger of creating symptomatic COVID-19 by 77 per cent.

Greater than three-quarters of the individuals had suppressed immune techniques and different circumstances that made them extra inclined to extreme illness.

 “Susceptible populations such because the immunocompromised typically aren’t in a position to mount a protecting response following vaccination and proceed to be susceptible to creating COVID-19,” Mene Pangalos, AstraZeneca’s govt vp for pharmaceutical analysis, mentioned in a press release. “With this primary international regulatory submitting, we’re one step nearer to offering an extra choice to assist defend in opposition to COVID-19 alongside vaccines.”

U.S. demand for antibody therapies soared over the summer time, notably in states like Florida, Louisiana and Texas, the place hospitalizations amongst unvaccinated sufferers threatened to overwhelm the well being care system.

The medication are laboratory-made variations of virus-blocking antibodies that assist battle off infections. The therapies assist the affected person by supplying concentrated doses of 1 or two antibodies.

The principle antibody remedy getting used within the U.S. is Regeneron’s dual-antibody cocktail.

The FDA has additionally approved the Regeneron product as safety for high-risk individuals in opposition to extreme COVID-19.

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